CFDA: Notice on carrying out special supervision and sampling inspection of Ginkgo biloba drugs in the third stage

Source: CFDA official website on September 8, 2015, CFDA issued the notice on carrying out the special supervision and sampling inspection of Ginkgo biloba drugs in the third stage, which requires that the detected unqualified drugs shall be subject to the CFDA on August 10 on the basis of the special supervision and sampling inspection of Ginkgo biloba drugs in the first and second stages The supplementary inspection method of Sophoricoside in Ginkgo biloba leaf extract, Ginkgo biloba leaf and Ginkgo biloba leaf capsule was issued for inspection, providing technical support for the investigation and handling of subsequent Ginkgo biloba drug cases Previously, CFDA has released the results of special sampling test of Ginkgo biloba drugs in the first and second stages In the first stage, 284 batches were inspected, among which 67 batches of unqualified drugs were detected, accounting for 23.6% of the total products, involving 24 drug manufacturers There are 60 batches of drugs that are unqualified in the self inspection of the enterprise, and the results of supervision sampling inspection are consistent with the results of the self inspection of the enterprise In the second stage, 118 batches of substandard drugs were detected in 194 batches, involving 31 drug manufacturers 102 batches of drugs from 29 enterprises are unqualified in self inspection, and the results of supervision sampling are consistent with those of self inspection The specific inspection requirements are as follows: (1) invite Beijing, Hebei, Liaoning, Jilin, Jiangsu, Zhejiang, Guangdong, Guangxi, Chongqing, Sichuan, Shaanxi, Gansu, etc 12 The provincial (District, city) food and drug supervision department shall organize the provincial (District, city) food and Drug Inspection Institute to inspect the unqualified drugs detected in the first and second stage of Ginkgo biloba drug supervision sampling inspection according to the supplementary inspection method for Sophoricoside inspection items Relevant provincial (District, city) food and drug inspection institutes shall immediately arrange the inspection and upload the inspection results through the "national drug sampling information system", and all the inspection work shall be completed before September 16, 2015 （2） The food and drug regulatory authorities of each province (district or city) are requested to organize the relevant drug inspection institutions in their own administrative regions to conduct the inspection of Ginkgo biloba extract and Ginkgo biloba leaf drugs in accordance with the notice of the State Food and Drug Administration on the inspection of Ginkgo biloba extract and Ginkgo biloba leaf drugs (SFDA [2015] 66) No.) for the unqualified Ginkgo biloba drugs detected in the spot check or in the case investigation, the sample retention shall be inspected according to the supplementary inspection method for Sophoricoside inspection items The test results shall be used as the basis or qualitative basis for investigation and treatment of follow-up cases in all provinces (districts and cities) （3） The Chinese Academy of inspection is requested to strengthen technical guidance to all regions If there is any difficulty in completing the inspection tasks in different regions, the Chinese Academy of inspection shall undertake the relevant inspection tasks （4） Drug testing institutions at all levels shall reasonably use samples to keep samples, so as to ensure the smooth development of the later retest work （5） If there is any problem in the implementation of the supplementary inspection method, please contact the China Inspection Institute, which shall arrange a special person to take charge of this work （6） The expenses for this special inspection shall be borne by the State Food and drug administration, and the food and Drug Administration of each province (District, city) shall pay in advance.